Cynthia Hahn

About Cynthia Hahn

Executive biomedical research professional with over 25 years of experience in human subject research, grants management, operations and compliance in academic and corporate environments. Provide industry and academic research organizations with intelligence, strategy and actionable operational solutions to improve the efficiency and compliance of biomedical research programs. Developed and managed a centralized research infrastructure for 22 hospitals,over 400 ambulatory centers and a separate 501c3 research institution with over employees and an operating budget in excess of $150 million. Negotiated resolution agreements and implemented Correction Action Plans (CAP) with the Office of Civil Rights (OCR) related to HIPAA.Originated positions and functions of the Chief Operating Officer, Research Compliance Officer, Chair of the Conflicts of Interest in Research Committee, Research Privacy Officer, and sequestering official for Research MisconductCo-investigator on multiple projects aimed at improving the environment for research compliance including serving as team lead on a federal public private partnership (CTTI) project, Advancing the Use of Central IRBs for Multicenter Clinical Trials, cited by the US government in its decision to adopt a single IRB review for multicenter clinical trialsProvided regulatory coordination and project management which led to the approval of two therapeutics: Buprenorphine/Naloxone as an outpatient alternative to methadone maintenance and Collagenase in the treatment of Dupuytryn’s Contracture

Experience

1. Managing Expert

   Advarra

   Jan 2018 — Present

   AccomplishmentsTransformed the business and clinical operations of a mobile clinical care service provider during the COVID pandemic to provide human research related services and collaboration to industry and academic partners interested in pursuing decentralized clinical trialsProvided interim research compliance and human research protection support to a large Academic Health SystemConducted a gap analysis and provided a framework for integration of research administration and programs between a large health system and universityDeveloped a research administrative infrastructure including risk analysis, organizational structure, business development, research compliance, human research protections, data protection, policies and procedures and financial forecasting for a new disease focused pediatric research instituteAdvise and provide research compliance guidance to the board and management of an established genome focused research institute and sponsor.

Education

• Ithaca College

  Liberal Arts (Politics)

  1990 — 1994

Skills

• Clinical Trials
• Hipaa
• Healthcare Consulting
• Staff Management
• Meeting Management
• Team Leadership
• Healthcare
• Nih
• Clinical Research
• Grants
• Health Policy
• Training & Development
• Regulatory Strategy
• Grants Administration
• Strategic Planning
• Leadership
• Compliance
• Strategy Development
• Staff Training
• Compliance Management
• Healthcare Management
• Hospitals
• Grant Management
• Policy Analysis
• Healthcare Information Technology
• Medicine
• Revenue Cycle
• Corporate Communications
• Academic Administration
• Public Speaking
• Strategic Partnerships
• Policy
• Regulatory Affairs
• Protocol
• Irb
• Institutional Research
• Government Compliance
• Research
• Fda
• Public Policy